RecruitingNot ApplicableNCT05993364

Efficacy of EFA in Acquired Brain Injury

Role of Expiratory Flow Acceleration in the Management of Bronchial Secrections in Severe Acquired Brain Injury: a Pilot Randomized Controlled Study

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Enrollment

20 participants

Start Date

Feb 19, 2024

Study Type

INTERVENTIONAL

Conditions

Lung Diseases, Obstructive Acquired Brain Injury Comparative Effectiveness Research

Summary

Acquired brain injury (ABI) is one of the biggest cause of death and disability in the world. Patients with ABI often have difficulties with swallow and breath. The study purpose is to evaluate if the Expiratory Flow Accelerator (EFA) technology has positive effects on the respiratory and swallowing function in patients with acquired brain injury (ABI). Researchers recruit patients at Centro Ettore Spalenza-Fondazione Don Carlo Gnocchi in Rovato, Italy. To partecipate, patients should satisfy certain eligibility criteria; they will not be enrolled if they satisfy exclusion criteria. If a patient can be recruited, researchers conduct the baseline assessment lasting 1 one week. After that, the patient will be randomized to the study or control group. If the patient is in the control group, he will receive a traditional rehabilitation treatment. Otherwise, the patient will receive an additional treatment with the EFA device. Researchers will assess again the patient (with the same procedures of baseline assessment) after 8 weeks of treatment. They want to see if the EFA device could help patients with ABI to improve their health conditions.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Age higher than 18 years old;
Hospitalization after diagnosis of Acquired Brain Injury (both traumatic and vascular)
Levels of Cognitive Functioning Scale (LCFS) score between 1and 5;
Presence of spontaneous breathing, at least during the day

Exclusion Criteria2

Need of mechanical ventilation for more than 12 hours a day;
Presence of tracheal stoma not properly healed after the removal of the tracheal cannula.

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Interventions

DEVICEFree Aspire with Expiratory Flow Accelerator (EFA) technology

Treatment sessions during which the EFA technology is used. Depending on the patient's clinical conditions, an oxygen additional support can be provided, while using the device. If present, during the sessions the tracheal cannula must be cuffed. Tracheal cannula aspiration must be provided when necessary. Sessions take place three times a day and take 20 minutes each time, from Monday to Saturday.

DEVICEIn-Exufflator Machine

Sessions using the In-Exufflator machine to improve the cough function, when the oxygen saturation decreases and the bronchial secretions increases.

OTHERTraditional respiratory treatment

Standard rehabilitative treatment to improve the secretions management, that includes: * A change of the patient posture every three hours; * Airways humidification depending on the secretions features; * Aspiration in the tracheal cannula whenever necessary.

OTHERTraditional swallowing treatment

Traditional rehabilitative treatment carried out by the speech and language pathologist in order to: * Obtain decannulation (when a tracheal cannula is applied) following the Bargellesi Protocol steps; * Improve oral structures strength and motility; * Improve oral and perioral sensitivity with thermal or gustative or tactile stimulations; * Improve the swallowing function with food trials of different consistencies, volume and temperature; * Improve swallow efficacy and safety through the prescription of compensatory postures;